A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the anti-HIV activity of these treatment regimens.
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
研究概览
详细说明
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483, administered three times daily. Treatment continues for 16 to 24 weeks. Per 07/19/94 amendment: At the end of 24 weeks, blinded treatment continues for an additional 4 weeks, at which time patients may receive open-label drug on an optional basis for 90 days.
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国
- Alabama Therapeutics CRS
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California
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Los Angeles、California、美国、90033
- USC CRS
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Palo Alto、California、美国
- Stanford CRS
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San Francisco、California、美国、94110
- Ucsf Aids Crs
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Colorado
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Aurora、Colorado、美国
- University of Colorado Hospital CRS
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Florida
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Miami、Florida、美国
- Univ. of Miami AIDS CRS
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University CRS
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Chicago、Illinois、美国、60612
- Rush Univ. Med. Ctr. ACTG CRS
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Chicago、Illinois、美国、60640
- Weiss Memorial Hosp.
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Chicago、Illinois、美国
- Cook County Hosp. CORE Ctr.
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Indiana
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Indianapolis、Indiana、美国
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
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Indianapolis、Indiana、美国
- Methodist Hosp. of Indiana
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Missouri
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Saint Louis、Missouri、美国
- Washington U CRS
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Saint Louis、Missouri、美国、63112
- St. Louis ConnectCare, Infectious Diseases Clinic
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New York
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Buffalo、New York、美国、14260
- SUNY - Buffalo, Erie County Medical Ctr.
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New York、New York、美国
- Beth Israel Med. Ctr. (Mt. Sinai)
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Rochester、New York、美国
- Univ. of Rochester ACTG CRS
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North Carolina
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Chapel Hill、North Carolina、美国、27514
- Unc Aids Crs
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Raleigh、North Carolina、美国
- Wake County Health and Human Services CRS
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Ohio
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Cincinnati、Ohio、美国
- Univ. of Cincinnati CRS
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Pennsylvania
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Philadelphia、Pennsylvania、美国
- Hosp. of the Univ. of Pennsylvania CRS
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Washington
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Seattle、Washington、美国、98104
- University of Washington AIDS CRS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
Concurrent Medication:
Required:
- PCP prophylaxis (trimethoprim/sulfamethoxazole, dapsone, or aerosolized pentamidine) in patients with CD4 count <= 200 cells/mm3.
Allowed:
- Topical antifungal agents, ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections, as medically indicated.
- Maintenance therapy for Mycobacteria disease with isoniazid, ethambutol, rifampin, pyrazinamide, clofazimine, ciprofloxacin, clarithromycin, or rifabutin.
- Maintenance therapy for toxoplasmosis with pyrimethamine, sulfadiazine, or clindamycin.
- Maintenance therapy for herpes simplex virus with acyclovir at <= 1000 mg/day.
- Recombinant erythropoietin and G-CSF, if indicated.
- Antibiotics for bacterial infections.
- Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics.
Concurrent Treatment:
Allowed:
- Localized radiation therapy and limited intralesional therapy for cutaneous Kaposi's sarcoma.
Patients must have:
- Documented HIV infection.
- Per 07/19/94 amendment, one of the following:
- CD4 count 150 - 350 cells/mm3 within 60 days prior to study entry AND prior AZT for no more than 12 months cumulative (given with or without ddI or ddC).
- CD4 count 50 - 350 cells/mm3 within 60 days prior to study entry AND no prior antiretroviral therapy.
- MT-2 cell assay within 60 days prior to study entry.
NOTE:
- Minimal Kaposi's sarcoma is permitted.
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
- Malignancy other than minimal Kaposi's sarcoma.
Concurrent Medication:
Excluded:
- Antiretroviral therapies (other than study drug).
- Biologic response modifiers.
- Systemic corticosteroids for > 21 consecutive days.
- Foscarnet.
- Systemic cytotoxic chemotherapy for a malignancy.
Patients with the following prior conditions are excluded:
- History of cataracts.
- History of intolerance to AZT at <= 600 mg/day.
- Unexplained temperature >= 38.5 degrees C that persists for any 7 days within the 30 days prior to study entry.
- Chronic diarrhea (defined as >= 3 stools per day) that persists for any 15 days within the 30 days prior to study entry.
Prior Medication:
Excluded:
- More than 6 months (more than 12 months per 07/19/94 amendment) cumulative prior therapy with AZT.
- Prior induction or maintenance therapy with foscarnet.
- Any investigational drug within 30 days prior to study entry.
- Prior SC-49483 or SC-48334.
- Prior ddC, ddI, or stavudine (d4T) as monotherapy.
- Interferon or interleukin within 30 days prior to study entry.
- Prior non-nucleoside reverse transcriptase inhibitors (e.g., NVP, ATV).
- Systemic corticosteroids for > 21 consecutive days.
- Acute treatment for a serious infection or any opportunistic infection within 14 days prior to study entry.
- Prior combination therapy with AZT, ddI, and/or ddC within 30 days prior to study entry.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:双倍的
合作者和调查者
调查人员
- 学习椅:Saag M
出版物和有用的链接
一般刊物
- Johnson VA, Bassett RL, Stanley KE, Saag MS, Fischl MA. Predictors of syncytium-inducing viral phenotype in a phase II double-blind trial of SC-49483 plus ZDV vs. ZDV. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:102 (abstract no 205)
研究记录日期
研究主要日期
学习开始
初级完成
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ACTG 259
- 11236 (DAIDS-ES)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
艾滋病毒感染的临床试验
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Hospital Clinic of Barcelona完全的
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Centers for Disease Control and PreventionGilead Sciences; CDC Foundation完全的
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的